Pharmaceutically acceptable composition containing ambroxol in non-salt form

Abstract

The invention relates to a medicinal composition of ambroxol in a non-salt form. Particularly, the invention especially relates to a composition comprising ambroxol in a base form and other oral substances with or without physiological activity or a drug container. The inventor surprisingly finds that when ambroxol is prepared into an oral preparation in a non-salt form, and especially a preparation such as a suspension, a dry suspension, a granule and the like needing to be diluted and prepared with water before drinking, the mouthfeel is significantly improved when compared with that of an ambroxol hydrochloride solution, and the ambroxol preparation has significantly slower absorption in vivo than an ambroxol hydrochloride preparation; and the realization of a slow-release effect which requires great effort on preparation process can be easily achieved. It is well known that the slow release of a drug can reduce drug side effects and increase security with the guarantee of curative effects.

Description

technical field [0001] The present invention relates to pharmaceutically acceptable compositions containing ambroxol in non-salt form. Specifically, the present invention especially relates to the composition of ambroxol in the form of a salt base and other oral substances or medicine containers with or without physiological activity. Background technique [0002] Ambroxol, English name Ambroxol, chemical name: trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol. [0003] Ambroxol is a well-known expectorant, which is mainly used for those who have thick sputum and are difficult to cough up. Although ambroxol has injections, sterile powder (freeze-dried form), tablets, capsules, sustained-release preparations, oral solutions, granules, etc. in pharmaceutical dosage forms, they all use ambroxol salts, especially Hydrochloride is used as an active ingredient, and it is made by adding other corresponding auxiliary materials. [0004] Ambroxol hydrochloride oral solution i...

AI Technical Summary

Problems solved by technology

At present, there is no better solution to the clinical application of this contradiction, which greatly reduces the compliance of the product, that is, some patients cannot take the medicine regularly as prescribed because of their unwillingness to take the medicine, so the therapeutic effect of the medicine cannot reach the expected value

[0005] The reason for the above phenomenon is that after ambroxol dissolves in water, it produces a relatively strong bitter and astringent taste, and in order to increase the solubility and make it in a solution state, the cosolvent ethanol and other auxiliary materials added cause a numb and spicy taste.